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OpportunityAnalyzer: Pancreatic Cancer - Opportunity Analysis and Forecasts to 2017

Summary

With five-year survival only approximately 5%, pancreatic cancer is characterized as a disease with some of the highest unmet need in oncology. This report focuses on the current treatment landscape, unmet needs, pipeline and commercial opportunity in the pancreatic cancer market with coverage of both the early stage resectable and advanced settings. Celgene’s Abraxane was launched in the US and Europe in 2013 and 2014, respectively, and was the first drug approved in this disease in nearly a decade. Due to the high unmet need, GlobalData forecasts the rapid uptake of Abraxane, and sales of this drug are expected to drive the overall pancreatic cancer market and are forecast to represent greater than 50% of total market sales in 2017. GlobalData also forecasts the launch of five new pipeline agents into the pancreatic cancer market. Despite the launch of new agents, GlobalData expects significant opportunities to remain for developers of drugs with predictive biomarker-driven strategies. The challenge for new entrants will be to design adequate clinical studies that assess pipeline drugs in carefully selected patient populations and incorporate the current standard-of-care chemotherapies, such as GemAbrax, as backbone regimens. With Big Pharma being actively involved in early-stage innovative projects, GlobalData expects clinical development in pancreatic cancer to accelerate at the end of the forecast period and beyond.

Highlights

Key Questions Answered

- What are the areas of highest unmet need in pancreatic cancer?
- What are the R&D and clinical trial design strategies pursued by companies in the pancreatic cancer space?
- What are the most promising pipeline agents for pancreatic cancer? How do their clinical and commercial attributes compare to one another and the current standard of care?
- What opportunities will remain for future players following the launch of these pipeline agents?
- What is the potential for predictive biomarkers and targeted therapies in the pancreatic cancer setting?
- What exciting, innovative approaches are being investigated in pancreatic cancer?

Key Findings

- The pancreatic cancer market, in the 6MM is forecasted to rapidly increase from $529m in 2012 to $1.63bn in 2017, at a CAGR of 25.2%. This growth is driven by the adoption of premium-priced Abraxane into clinical practice, as well as the launch of five novel pipeline agents towards the end of the forecast period.
- Although the approval of Abraxane has been welcomed by KOLs, they are not satisfied with the overall survival benefit of two months compared with gemcitabine monotherapy, and call for novel, predictive, biomarker-driven targeted therapies in order to substantially extend survival.
- Of the pipeline agents expected to launch during the forecast period, only NewLink Genetics’ immunotherapy algenpantucel-L is being investigated in the early-stage resectable setting. GlobalData expects the lack of treatment options for resectable patients to facilitate the rapid uptake of this therapy in the US.
- The early stage pipeline for pancreatic cancer is strong and is indicative of the remaining high commercial opportunities. Strikingly, in comparison with the late-stage pipeline, Big Pharma is playing a much stronger role in the investigation of these strategies.

Scope

- Overview of pancreatic cancer, including epidemiology, etiology, pathophysiology, symptoms, prognosis, and clinical staging.
- Topline pancreatic cancer therapeutics market revenue from 2012–2017. Annual cost of therapy, and major marketed and pipeline drug sales in this forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the pancreatic cancer therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline drugs. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the 6MM pancreatic cancer therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the 6MM pancreatic cancer market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 6MM pancreatic cancer therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

OpportunityAnalyzer: Pancreatic Cancer - Opportunity Analysis and Forecasts to 2017
1 Table of Contents

2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 17
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 20
3.2 Prognosis 21
3.3 Clinical Staging 21
3.4 Symptoms 25
4 Epidemiology 26
4.1 Disease Overview 26
4.2 Risk Factors and Comorbidities 26
4.2.1 The risk of developing pancreatic cancer increases with age 27
4.2.2 Tobacco smokers have a two-fold increased risk of pancreatic cancer 27
4.2.3 Diabetes and obesity increase the risk of developing pancreatic cancer 27
4.2.4 At least 10% of pancreatic cancer cases result from a hereditary predisposition 28
4.3 Global Trends 29
4.3.1 United States 29
4.3.2 France 30
4.3.3 Germany 31
4.3.4 Italy 32
4.3.5 Spain 33
4.3.6 United Kingdom 34
4.4 Forecast Methodology 35
4.4.1 Sources Used 36
4.4.2 Forecast Assumptions and Methods 38
4.4.3 Sources Not Used 40
4.5 Epidemiology Forecast 40
4.5.1 Incident Cases of Pancreatic Cancer 40
4.5.2 Total Five-Year Prevalent Cases of Pancreatic Cancer 47
4.6 Discussion 49
4.6.1 Conclusions on Epidemiological Trends 49
4.6.2 Limitations of the Analysis 50
4.6.3 Strengths of the Analysis 50
5 Current Treatment Options 52
5.1 Overview 52
5.2 Product Profiles — Major Brands 55
5.2.1 Abraxane 55
5.2.2 Gemcitabine 59
5.2.3 Tarceva 63
6 Unmet Needs Assessment and Opportunity Analysis 67
6.1 Overview 67
6.2 Unmet Needs Analysis 69
6.2.1 Therapies That Improve Overall Survival Outcomes for Advanced Patients 69
6.2.2 Effective Adjuvant Treatments That Prevent Recurrence of Disease 70
6.2.3 Earlier Diagnosis of Disease 71
6.2.4 Discovery of Predictive Biomarkers and Understanding of Underlying Causes of Disease 71
6.2.5 Treatment Options for Gemcitabine-Refractory Metastatic Patients 72
6.3 Opportunity Analysis 73
6.3.1 Predictive Biomarker-Driven Targeted Therapies in Combination with Chemotherapy Regimens 73
6.3.2 Treatment for Patients with Early-Stage, Localized Pancreatic Cancer 74
6.3.3 Target Patients with Poor Performance Status 75
6.3.4 Effective Drug Delivery 76
6.3.5 Establish New Chemotherapy to be Standard-of-Care Cytotoxic 77
6.3.6 Development of New Standard of Care for Gemcitabine-Refractory Advanced Patients 78
7 Research and Development Strategies 79
7.1 Overview 79
7.1.1 Reformulation strategies 79
7.1.2 Small/Medium-Sized Pharmaceutical Companies Driving RandD 80
7.1.3 Large Pharmaceutical Companies Betting On Targeted Drug Approaches 81
7.2 Clinical Trial Design 82
7.2.1 Overview 82
7.2.2 Overall Survival is the Primary Endpoint of Choice in Both Adjuvant and Metastatic Trials 85
7.2.3 The Majority of Metastatic Trials Are in Second-Line and Later Patients 86
7.2.4 Gemcitabine: Backbone Therapy and Standard Active Comparator for First-Line Metastatic Trials 87
8 Pipeline Assessment 89
8.1 Overview 89
8.2 Promising Drugs in Clinical Development 91
8.2.1 Algenpantucel-L 92
8.2.2 TH-302 96
8.2.3 Lipoplatin 101
8.2.4 MM-398 104
8.2.5 Glufosfamide 109
8.2.6 90Y-Clivatuzumab Tetraxetan 112
8.3 Innovative Early-Stage Approaches 116
8.3.1 Vaccine and Immunotherapy Combination 118
8.3.2 JAK Inhibition 119
8.3.3 Dual MEK/PI3K inhibition 120
8.3.4 Cancer Stem Cell Targeting 123
8.3.5 Poly (ADP-Ribose) Polymerase Inhibitors 125
8.3.6 Drug Delivery Mechanisms 126
8.3.7 Hedgehog Pathway 127
9 Pipeline Valuation Analysis 130
9.1 Clinical Benchmarking of Key Pipeline Drugs 131
9.2 Commercial Benchmarking of Key Pipeline Drugs 134
9.3 Competitive Assessment 137
9.4 Top-Line Five-Year Forecast 138
9.5 US 141
9.6 Europe 143
10 Appendix 145
10.1 Bibliography 145
10.2 Abbreviations 163
10.3 Methodology 167
10.4 Forecasting Methodology 167
10.4.1 Diagnosed Pancreatic Cancer Patients 167
10.4.2 Percent Drug-Treated 168
10.4.3 Drugs Included in Each Therapeutic Class 168
10.4.4 Launch and Patent Expiry Dates 168
10.4.5 General Pricing Assumptions 169
10.4.6 Individual Drug Assumptions 170
10.4.7 Generic Erosion 174
10.5 Physicians and Specialists Included in this Study 175
10.6 About the Authors 176
10.6.1 Authors 176
10.6.2 Epidemiologists 177
10.6.3 Global Head of Healthcare 177
10.7 About GlobalData 178
10.8 Disclaimer 178

1.1 List of Tables

Table 1: AJCC TNM Classification System for Pancreatic Cancer 22
Table 2: AJCC TNM Staging System for Pancreatic Cancer 23
Table 3: Common Pancreatic Cancer Symptoms 25
Table 4: Risk Factors for Pancreatic Cancer 26
Table 5: 6MM, Sources of Pancreatic Cancer Incidence Data 36
Table 6: 6MM, Incident Cases of Pancreatic Cancer, Ages ?15 Years, Men and Women, Select Years, 2012-2022 41
Table 7: 6MM, Incident Cases of Pancreatic Cancer, by Age, Men and Women, N, 2012 42
Table 8: 6MM, Incident Cases of Pancreatic Cancer, by Sex, Ages ?15 Years, N (Row %), 2012 44
Table 9: 6MM, Five-Year Prevalent Cases of Pancreatic Cancer, Ages ?15 Years, Men and Women, Select Years, 2012-2022 48
Table 10: Leading Treatments for Pancreatic Cancer in the US and 5EU 54
Table 11: Product Profile - Abraxane 57
Table 12: Abraxane SWOT Analysis 59
Table 13: Gemcitabine SWOT Analysis 62
Table 14: Product Profile - Tarceva 64
Table 15: Tarceva SWOT Analysis 66
Table 16: Overall Unmet Needs - Current Level of Attainment 67
Table 17: Design of Pipeline Phase III Trials in Pancreatic Cancer 84
Table 18: Pancreatic Cancer - Late Stage Pipeline 91
Table 19: Product Profile - Algenpantucel-L 94
Table 20: Algenpantucel-L SWOT Analysis 96
Table 21: Product Profile - TH-302 99
Table 22: TH-302 SWOT Analysis 101
Table 23: Product Profile - Lipoplatin 103
Table 24: Lipoplatin SWOT Analysis 104
Table 25: Product Profile - MM-398 107
Table 26: MM-398 SWOT Analysis 108
Table 27: Product Profile - Glufosfamide 110
Table 28: Glufosfamide SWOT Analysis 111
Table 29: Product Profile - 90Y-Clivatuzumab Tetraxetan 114
Table 30: 90Y-Clivatuzumab Tetraxetan SWOT Analysis 115
Table 31: Early-Stage Pipeline Products in Pancreatic Cancer 117
Table 32: Clinical Benchmarking of Key Pipeline Drugs - Pancreatic Cancer 131
Table 33: Commercial Benchmarking of Key Pipeline Drugs - Pancreatic Cancer 134
Table 34: Top-Line Sales Forecast ($m) for Pancreatic Cancer, 2012-2017 139
Table 35: Key Events Impacting Sales for Pancreatic Cancer, 2012-2017 142
Table 36: Pancreatic Cancer Market - Drivers and Barriers, 2013 142
Table 37: Key Launch Dates 2012-2017 168
Table 38: Key Patent Expiries 2012-2017 169

1.2 List of Figures

Figure 1: Pancreatic Cancer Staging According to the AJCC TNM System 24
Figure 2: US, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008 29
Figure 3: France, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008 30
Figure 4: Germany, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008 31
Figure 5: Italy, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008 32
Figure 6: Spain, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008 33
Figure 7: UK, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008 34
Figure 8: 6MM, Incident Cases of Pancreatic Cancer, Ages ?15 Years, Men and Women, Select Years, 2012-2022 41
Figure 9: 6MM, Incident Cases of Pancreatic Cancer, by Age, Men and Women, N, 2012 43
Figure 10: 6MM, Incident Cases of Pancreatic Cancer by Sex, Ages ?15 Years, 2012 44
Figure 11: 6MM, Age-Standardized Pancreatic Cancer Incidence, 2012 45
Figure 12: 6MM, Incident Cases of Pancreatic Cancer by Stage at Diagnosis, Ages ?15 Years, Men and Women, 2012 46
Figure 13: 6MM, Total Incident Biomarker Cases of Pancreatic Cancer, Ages ?15 Years, Men and Women, 2012 47
Figure 14: 6MM, Total Five-Year Prevalent Cases of Pancreatic Cancer, Ages ?15 Years, Men and Women, Select Years, 2012-2022 48
Figure 15: Competitive Assessment of Late-Stage Pipeline Agents in Pancreatic Cancer, 2012-2017 137
Figure 16: Global Sales for Pancreatic Cancer by Region, 2012-2017 140

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